EU-Wide Advantages & Opportunities for the HORIZON-HLTH-2025-03-STAYHLTH-01 Call

1. Single Market Access (450+ million citizens)

• Unified playground for med-tech & digital health: Once a device/app/service receives a CE-mark under the Medical Device Regulation (MDR) or the In-Vitro Diagnostic Regulation (IVDR) it can be commercialised in all 27 Member States without additional national approvals, massively reducing go-to-market friction for innovations targeting intellectual disabilities (ID).

• Common reimbursement pathways are emerging (e.g. EU HTA Regulation from 2025, European Health Data Space): pilots can be designed with pan-EU uptake in mind, boosting market attractiveness for investors.

• Large, diverse user base enables developers to train AI/ML algorithms on multilingual, multicultural datasets, increasing robustness and fairness while complying with the AI Act and GDPR.

2. Cross-Border Collaboration & Knowledge Exchange

• Multinational consortia requirement already embedded in Horizon Europe encourages partnerships between clinical centres, tech SMEs, social-care providers, family associations and SSH researchers across borders.

• Leverage European Reference Networks (ERNs) on rare developmental disorders for patient recruitment and shared biobanking.

• Tap into COST Actions for networking funds and early career researcher mobility.

• Living Labs in multiple Member States allow real-life testing of assistive technologies in diverse care settings (urban/rural, different welfare models), accelerating user-centred design.

• Mutual recognition of professional qualifications eases short-term staff exchanges (e.g. specialised therapists, nurses), fostering rapid upskilling.

3. Alignment with Flagship EU Strategies

• European Strategy for the Rights of Persons with Disabilities 2021-2030: proposals directly contribute to priority 1 “EU disability card & accessible services” and priority 2 “Independent living & deinstitutionalisation”.

• European Care Strategy (2022): addresses informal carers’ burden; projects can pilot models that feed into the upcoming Council Recommendations on Long-Term Care.

• Digital Decade / Digital Europe Programme: integration of secure health data spaces, AI and high-performance computing for personalised interventions.

• Green Deal & Circular Economy: home-based digital solutions reduce transport and energy use associated with institutional care; eco-design of assistive devices qualifies for green public procurement.

• EU Child Guarantee & European Pillar of Social Rights: early diagnostics and inclusive education tools support Member States in meeting social inclusion targets.

4. Regulatory Harmonisation Benefits

• Single ethical & data-protection framework via GDPR + Clinical Trial Regulation (CTR) enables creation of EU-wide paediatric ID cohorts with simplified cross-border data transfer (using EDPB-endorsed codes of conduct).

• Harmonised standards for cognitive accessibility (EN 301 549, ISO 21801) allow developers to certify once and sell everywhere, de-risking scale-up.

• The forthcoming EU Disability Card facilitates recognition of disability status across borders, opening paths for interoperable digital wallets and service entitlements tested within the project.

5. Access to Europe’s Innovation Ecosystem

• >3,000 universities & RTOs eligible under Horizon Europe offer state-of-the-art genomics, neuroimaging, and social science expertise.

• European Digital Innovation Hubs (EDIHs) provide SMEs with testing facilities, cybersecurity labs and business mentoring at no cost.

• EIT Health & EIT Digital can act as accelerators post-project, providing market validation, regulatory coaching and investor matchmaking.

• Open Science mandates (EOSC) increase visibility, citation and secondary innovation on project outputs (datasets, algorithms, policy briefs).

6. Funding Synergies & Blending Opportunities

• EU4Health & ESF+: upscale proven care models, finance workforce training or mental-health support programmes for carers.

• ERDF / Cohesion Policy 2021-27: invest in regional ID-care infrastructure or Living Labs emerging from the project, especially in less-developed regions.

• InvestEU – Social Investment & Skills window: patient-centred integrated-care services can access repayable finance once business models are validated.

• EIC Pathfinder / Accelerator: high-risk deep-tech components (e.g. brain-computer interfaces, gene-editing tools) can be fast-tracked to market readiness.

• Digital Europe: possible top-ups for AI training data, cybersecurity or high-performance computing resources.

7. Scale, Replicability & Societal Impact

• Pan-EU clinical guidelines and caregiver training curricula developed under the project can be endorsed by EU agencies (EMA, ECDC) and professional societies, ensuring uniform quality standards.

• Transitional care models validated in 3-4 Member States can be replicated EU-wide through Joint Actions or Erasmus+ vocational modules.

• Standardised KPIs aligned with the EU Social Scoreboard enable policymakers to benchmark quality-of-life improvements and justify reforms.

• Multilingual, culturally adapted digital tools reach Europe’s 24 official languages, enhancing inclusivity and market penetration.

8. Unique Strategic Value at EU Level

1. Economies of scale: pooled resources reduce duplication of rare-disease research and enable larger sample sizes, boosting statistical power and generalisability.

2. Policy influence: evidence can directly feed into EU Parliament Disability Intergroup, shaping future legislation on accessibility, carers’ rights and digital health.

3. Resilience & strategic autonomy: nurturing EU-based supply chains for assistive tech and neuropharma supports the Open Strategic Autonomy agenda.

4. Global leadership & export potential: EU-validated standards for cognitively accessible digital services become benchmarks adopted by WHO and ISO, positioning European firms for global markets.

9. Actionable Next Steps for Applicants

• Map consortium partners to at least 10 Member States + 1 associated country to maximise geographic coverage and eligibility for bonus evaluation points (widening participation, gender dimension, SSH).

• Engage national contact points for cohesion funds early to design post-Horizon scaling pathways.

• Allocate WP on policy translation & standardisation to interface with CEN/CENELEC and EU disability agencies.

• Budget for joint clustering activities with Cluster 2 TRANSFO-09 projects to co-create social innovation pilots.

In summary, building and executing this project at the EU rather than national level multiplies market reach, leverages harmonised regulations, unlocks blended financing, catalyses cross-disciplinary excellence and positions Europe as the global frontrunner in improving the lives of persons with intellectual disabilities and their families.